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Clinical Calibration & Validation of a Next-Generation Blood Pressure Monitor for Patient Management (CCV)

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ClinicalTrials.gov Identifier: NCT03015363
Recruitment Status : Unknown
Verified February 2018 by Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : February 20, 2018
Sponsor:
Collaborators:
Horizon Health Network
Cloud Diagnostics, Incorporated
New Brunswick Health Research Foundation
Information provided by (Responsible Party):
Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick

Tracking Information
First Submitted Date January 5, 2017
First Posted Date January 10, 2017
Last Update Posted Date February 20, 2018
Study Start Date November 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2017)
  • Systolic pressure [ Time Frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure. ]
  • Diastolic pressure [ Time Frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter measurements on day of cardiac catheterization procedure. ]
Original Primary Outcome Measures
 (submitted: January 9, 2017)
  • Systolic pressure [ Time Frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter mesurements on day of cardiac catheterization procedure. ]
  • Diastolic pressure [ Time Frame: Simultaneous non-invasive blood pressure device and intra-arterial fluid-filled pressure catheter mesurements on day of cardiac catheterization procedure. ]
Change History
Current Secondary Outcome Measures
 (submitted: January 11, 2017)
  • Pulse rate [ Time Frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure. ]
  • Breathing rate [ Time Frame: Non-invasive blood pressure device measurements on day of cardiac catheterization procedure. ]
Original Secondary Outcome Measures
 (submitted: January 9, 2017)
  • Pulse rate [ Time Frame: Non-invasive blood pressure device mesurements on day of cardiac catheterization procedure. ]
  • Breathing rate [ Time Frame: Non-invasive blood pressure device mesurements on day of cardiac catheterization procedure. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Calibration & Validation of a Next-Generation Blood Pressure Monitor for Patient Management
Official Title Comparison, Calibration, and Validation of the Non-invasive Cloud DX Pulsewave Health MonitorTM With Direct Invasive Radial and Central Arterial Measurements During Cardiac Catheterization
Brief Summary The objective of the Cloud DX Pulsewave Health Monitor study is to prospectively calibrate and validate a novel, non-invasive wrist cuff blood pressure device against the gold standard for hemodynamic monitoring (intra-arterial pressure) in voluntarily consented patient participants who are scheduled for an elective cardiac catheterization procedure for clinically valid reasons.
Detailed Description

The Cloud DX Pulsewave Health Monitor is a non-invasive wrist cuff blood pressure device that is licensed by Health Canada with Food and Drug Administration approval. Systolic and diastolic pressures are measured via the arterial pulse waveform of the left radial artery. Initially, the blood pressure algorithm was created and calibrated using the auscultatory method. The purpose of this study is to calibrate the device to the clinical gold standard of peripheral and central intra-arterial pressures.

The device acquires a pulse signal in real-time, stores signal and measurement data, and displays stored signal and measurement data for interpretation via internet servers where it is accessible by end-users (physicians and/or patients). The system provides secure accounts for both in-patient and out-patient monitoring. Cloud DX's Pulsewave Health Monitor servers are housed in a secure data center. Privacy measures are to SSAE16 SOC-1 Type-II compliance: 1) restricted secure access, 2) dedicated firewall, 3) HTTPS channel communication via website, 4) self-encrypting hard-drives rendered useless if removed from the server.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients scheduled for an elective, non-emergent cardiac catheterization with right radial access; exclusion criteria being no history of peripheral vascular disease, no previous coronary artery bypass graft, no precious percutaneous coronary intervention, abdominal aortic aneurysm, arrhythmia, hand/body tremor, nor bilateral arm pressure inequality during history and physical.
Condition Hypertension
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Melville S, Teskey R, Philip S, Simpson JA, Lutchmedial S, Brunt KR. A Comparison and Calibration of a Wrist-Worn Blood Pressure Monitor for Patient Management: Assessing the Reliability of Innovative Blood Pressure Devices. J Med Internet Res. 2018 Apr 25;20(4):e111. doi: 10.2196/jmir.8009.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 9, 2017)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ≥ 19 years of age
  • Patients recommended by their cardiologist for a first-time, elective cardiac catheterization procedure
  • Wrist circumference between 13.5cm - 23cm (5.3 - 9.1in.)
  • Bilateral arm blood pressure equality (systolic within ±10mmHg; diastolic within ±5mmHg) on 2 separate readings (Nurse Associate & TRA)
  • Willing to volunteer to participate and to sign the study specific informed consent form

Exclusion Criteria:

  • No history of peripheral vascular disease, no previous percutaneous coronary intervention, nor previous coronary artery bypass graft
  • No arrhythmia
  • No abdominal aortic aneurysm
  • No hand/body tremor
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03015363
Other Study ID Numbers RS#: 2013-1919
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Sohrab Lutchmedial, MD, FRCPC, Cardiovascular Research New Brunswick
Study Sponsor Cardiovascular Research New Brunswick
Collaborators
  • Horizon Health Network
  • Cloud Diagnostics, Incorporated
  • New Brunswick Health Research Foundation
Investigators
Principal Investigator: Sohrab Lutchmedial, MD, FRCPC Cardiovascular Research New Brunswick
PRS Account Cardiovascular Research New Brunswick
Verification Date February 2018